Heart Health News

Official: Pharmacy Tied to Meningitis Outbreak May Have Broken State Law

THURSDAY, Oct. 11 (HealthDay News) -- The company at the center
of the ongoing meningitis outbreak appears to have violated
Massachusetts law by producing and distributing large quantities of
a contaminated steroid compound, a state health official said
Thursday.

According to Massachusetts law, so-called compounding pharmacies
like the company in question -- the New England Compounding Center
-- are only licensed to produce medications to fill single
prescriptions for individual patients, said Dr. Madeleine
Biondolillo, director of the Department of Public Health's Bureau
of Health Care Safety and Quality.

"Through the investigation, it looks like they have violated that aspect of the state licensing regulations despite their assertion that they were operating under the regulation," Biondolillo said during an afternoon news conference.

"Yesterday, the Massachusetts board of pharmacies issued an alert to all compounding pharmacies to reinforce with them the rules they must abide by in Massachusetts," she added. "Compounding can only be conducted upon the receipt of a patient-specific prescription."

Biondolillo said more oversight of compounding pharmacies is
needed, both on the state and federal levels.

Compounding pharmacies -- which historically started out as
community-based neighborhood druggists -- combine, mix or alter
ingredients to create specific drugs to meet the specific needs of
individual patients, according to the U.S. Food and Drug
Administration. Such customized drugs are frequently required to
fill special needs, such as a smaller dose, or the removal of an
ingredient that might trigger an allergy in a patient.

But over time, the practices of some compounding pharmacies have
expanded, often beyond their intended limits, experts
explained.

As of Thursday, 170 people had confirmed meningitis infections
due to the contaminated steroids and 14 had died. These illnesses
and deaths occurred in 11 of the 23 states where the steroids were
shipped, Dr. J. Todd Weber, chief of U.S. Centers for Disease
Control and Prevention's Prevention and Response Branch, Division
of Healthcare Quality Promotion, said during the news
conference.

Meningitis is a potentially fatal inflammation of the lining of
the brain and spinal cord.

Fungus linked to the outbreak has been found in 50 vials of the
drug taken from the manufacturer and from pain clinics around the
country, Deborah Autor, the FDA's deputy commissioner for global
regulatory operations and policy, said at the news conference.

The company is believed to have shipped more than 17,000 vials
of the steroid drug, called methylprednisolone acetate, to 23
states.

"The first cases from Tennessee had an infection from a fungus known as aspergillus, the CDC's Weber said. "Since that time, confirmed cases have all had infection caused by a different fungus known as exserohilum."

Exserohilumm infection has been confirmed in 10 people with
meningitis, and aspergillus has been confirmed in only one person
-- the first case, Weber said. Both types of infection are
extremely rare, he said, adding, "This is new territory for public
health and the clinical community."

As many as 14,000 people may have been exposed to the
contaminated steroids, Weber said. The CDC has so far been able to
contact some 11,000 of those patients, he said.

The most serious infections have been reported by those
receiving injections in the lower back, near the spine, to relieve
chronic back pain. Others have gotten shots for pain in joints like
the knee, ankle or shoulder, Weber said.

Weber also reported the first case of infection in someone who
received an injection in a joint. "This person received an
injection from one of the three recalled lots [recalled by the New
England Compounding Center]," he said. Whether the infection is
meningitis hasn't been confirmed yet, he said.

The New England Compounding Center was shut down on Oct. 3,
Autor said. Massachusetts officials have also pulled the company's
license to operate.

Autor said the FDA also inspected another Massachusetts-based
compounding pharmacy, Ameridose, which is affiliated with the New
England Compounding Center. That inspection failed to turn up any
irregularities and no recall of its products has occurred so far,
she said.

Please be aware that this information is provided to supplement the care provided by your physician. It is neither intended nor implied to be a substitute for professional medical advice. CALL YOUR HEALTHCARE PROVIDER IMMEDIATELY IF YOU THINK YOU MAY HAVE A MEDICAL EMERGENCY. Always seek the advice of your physician or other qualified health provider prior to starting any new treatment or with any questions you may have regarding a medical condition.